Background:To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex ? in Chinese patients with premenopausal breast cancer. Methods:From October 2020 to November 2021, 188 premenopausal breast cancer patients were enrolled in 34 hospitals and randomized 1:1 to receive either LY01005 or Zoladex ? every 28 days for a total of three injections. All patients concomitantly received oral tamoxifen (TAM). The primary efficacy endpoint was cumulative probability of maintaining menopausal level [oestradiol (E2) ≤30 pg/ml] from day 29 to day 85. The second efficacy endpoint included changes in E2, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) compared with the baseline. Pharmacokinetics (PK), pharmacodynamics (PD), and safety were analyzed. The study also evaluated the pharmacokinetic and pharmacodynamic characteristics of LY01005. Results:A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex ?. Cumulative probabilities of maintaining menopausal level (E2≤30 pg/ml) from day 29 to day 85 were 93.1% for LY01005 and 86.3% for Zoladex ?. The between-group difference was 6.8% (95% CI: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex ? group. Changes in E2, LH, and FSH levels compared with the baseline were equivalent between the two groups (E2: 89.34% to 90.23% vs. 82.11% to 85.02%; LH: 88.89% to 95.52% vs. 89.70% to 97.02%; FSH: 75.36% to 80.85% vs.73.07% to 80.24%, respectively). After three consecutive doses of LY01005, the LH and FSH levels of the subjects showed a transient increase after the first dose, reached a peak on the second day and then started to decrease. The LH and FSH reached a lower level and remained at or below that level until the 85th day. Both treatments were well-tolerated. Conclusion:LY01005 is as effective as Zoladex ? in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.

Background:To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex ? in Chinese patients with premenopausal breast cancer. Methods:From October 2020 to November 2021, 188 premenopausal breast cancer patients were enrolled in 34 hospitals and randomized 1:1 to receive either LY01005 or Zoladex ? every 28 days for a total of three injections. All patients concomitantly received oral tamoxifen (TAM). The primary efficacy endpoint was cumulative probability of maintaining menopausal level [oestradiol (E2) ≤30 pg/ml] from day 29 to day 85. The second efficacy endpoint included changes in E2, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) compared with the baseline. Pharmacokinetics (PK), pharmacodynamics (PD), and safety were analyzed. The study also evaluated the pharmacokinetic and pharmacodynamic characteristics of LY01005. Results:A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex ?. Cumulative probabilities of maintaining menopausal level (E2≤30 pg/ml) from day 29 to day 85 were 93.1% for LY01005 and 86.3% for Zoladex ?. The between-group difference was 6.8% (95% CI: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex ? group. Changes in E2, LH, and FSH levels compared with the baseline were equivalent between the two groups (E2: 89.34% to 90.23% vs. 82.11% to 85.02%; LH: 88.89% to 95.52% vs. 89.70% to 97.02%; FSH: 75.36% to 80.85% vs.73.07% to 80.24%, respectively). After three consecutive doses of LY01005, the LH and FSH levels of the subjects showed a transient increase after the first dose, reached a peak on the second day and then started to decrease. The LH and FSH reached a lower level and remained at or below that level until the 85th day. Both treatments were well-tolerated. Conclusion:LY01005 is as effective as Zoladex ? in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.

ObjectiveTo study the neuron protection mechanism of Uncariae Ramulus Cum Uncis extract for the MPTP-induced PD mice.MethodsC57BL/6 mice were randomly divided into control group, model group, Uncariae Ramulus Cum Uncis extract group and madopar group, and injected with MPTP in abdominal cavity. Behavior test was used to detect grabbing capacity and body movement coordination capacity: three biochemical indexes (SOD, MDA, GSH-Px) were detected by biochemical process and the activity of two immune enzyme-linked indexes (IL-1β, IL-6) were detected by enzymelinked immunosorbent assay.ResultsCompared with the control group, the autonomic activity numbers of mice increased and climbing pole time decreased in the model group (P<0.05), enzymatic activity of SOD and GSH-Px decreased significantly and the contents of MDA, IL-1β and IL-6 increased obviously (P<0.01). Compared with model group, the autonomic activity numbers of mice increased and climbing pole time decreased in the Uncariae Ramulus Cum Uncis extract group and madopar group (P<0.05). Enzymatic activity of SOD and GSH-Px increased and the contents of MDA and IL-1β and IL-6 decreased (P<0.05,P<0.01).ConclusionUncariae Ramulus Cum Uncis extract can reduce neuronic apoptosis PD mice, whose therapeutic action may be realized through eliminating oxygen free radicals, improving oxidation resistance and reducing inflammatory reactions.

Objective To optimize the prescription ofBaichanting Tablets by the central composite design-response surface methodology.Methods The doses of MCC, cCMC-Na, SiO2, and magnesium stearate were set as investigation factors; disintegration time and moisture rate were set as indexes. Linear equation quadratic polynomial described mathematic relationship of disintegration time and moisture rate with other four influence factors. Response surface was described according to the optimal mathematic models; the optimal prescription was chosen; predictive analysis was conducted.ResultsThe relationship of disintegration time and moisture rate with other four influence factors could not be described by linear equation. When quadratic polynomial matching was used, correlation coefficients were 0.837 9 and 0.923 1, with relatively high reliability. Optimal prescription contained 30.6%MCC, 10%cCMC-Na, 0.30%SiO2, and 0.10% magnesium stearate. The theoretical value and predicted value deviations of the disintegration time limit and moisture absorption rate were within 5%.Conclusion The predictability of the established model is good. Application of central composite design-response surface methodology can precisely optimize the prescription ofBaichanting Tablets.

Objective To analyze the clinical features,therapeutic effect and prognosis in patients with bone pain induced by malignant bone me?tastasis as well as the rationality of analgesic application,so as to improve the level of diagnosis and treatment for metastatic bone pain. Methods Totally 123 patients with pain due to malignant bone metastasis received antitumor therapy and analgesic therapy based on standardized three?step guidelines. Their clinical characteristics were retrospectively analyzed. Results The total pain relief rate was 85.4%and the pain was significantly relieved(P<0.05). The DUI value of each narcotic agent was close to 1 and the application of narcotic agents tended to be rational. The Kaplan?Meier survival analysis showed that patients with moderate pain had longer survival time than those with severe pain(P=0.015). The survival rate of patients with significant pain relief after treatment was higher than those unrelieved(P=0.021). The survival rate of patients without visceral me?tastasis was higher than those with visceral metastasis(P=0.000). The COX multivariate analysis indicated that the pain intensity and visceral me?tastasis were independent risk factors influencing patient prognosis. Conclusion Standard treatment can improve symptoms in most patients with bone metastasis and prolong survival time. Opioids have satisfactory analgesic effect for moderate to severe pain and the adverse reactions can be tol?erated.

Background and purpose: Malignant tumors often relapsed or metastasized after first-line chemotherapy and needed second-line or above treatment. We conducted this study to deifne the maximum-tolerated dose (MTD) of lobaplatin with ifxed docetaxel for Chinese patients in previously treated solid tumors. Methods:Escalating doses of lobaplatin with fixed docetaxel were administered in a modified Fibonacci sequence. The initial doses were lobapla-tin 30 mg/m2 and docetaxel 60 mg/m2, respectively. Escalating doses was 5 mg/m2. The regimen was repeated every 21 days. If no dose-limiting toxicity (DLT) was observed, the next dose level was applied. The procedures were repeated until DLT appeared. The MTD was declared to be one dose level below the level at which DLT appeared. Results:Seventeen patients received fifty-eight cycles chemotherapy at lobaplatin of levelⅠ(30mg/m2), levelⅡ(35 mg/m2)and levelⅢ(40 mg/m2). Cases of complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) for the whole group were 0, 1, 10 and 3, respectively. Response rate (RR, CR+PR) and disease control rate (DCR, CR+PR+SD) were 7.1%(1/14) and 78.6%(11/14), respectively. The most common toxicity was leukopenia. Three DLTs occurred in 3 patients in the whole group, including 2 DLTs in dose levelⅢ. We declared thus levelⅡwas MTD. Conclusion:MTD of lobaplatin in our re-search was 35 mg/m2 combined with fixed dose of docetaxel. This combination regimen was well tolerated.

Objective To evaluate the efficacy of the autologous epidermal grafting combining with NB-UVB radiation on the treatment of stable vitiligo.Methods Autologous epidermal graft acquired by suction blister under negative pressure were transplanted onto the laser-abraded depigmented areas,then the narrow-band UVB radiation was given after grafting to 35 patients with stable vitiligo.The onset time and the area repigmentation of every epidermal graft 3 months latter were observed (digital image contrasted before and after treatment).The results were compared with 37 cases only treated with autologous epidermal grafting.Results Both onset time and the cure rate in combined treatment group were statistically significant (P＜0.05) as compared with control group.Conclusions The combination of autologous epidermal grafting with NB-UVB radiation can shorten the onset time of repigmentation and promote generation and extension of the melanin.

OBJECTIVE:To observe the curative effect of Danhong injection in treating cerebral infarction.METHODS:30 patients(trial group) were assigned to receive Danhong injection,while 26(control group) to receive Ligustrazine injection.The neurologic impairment score,clinical efficacy and ADRs during medication were compared between the two groups.RESULTS:The total effective rates in trial group vs.in control group were 86.67% vs.65.38%,showing significant differences between the two groups(P

BACKGROUNDTo study the diagnostic value of detection of carcinoembryonic antigen (CEA), cancer antigen 125 (CA125), cancer antigen 153 (CA153) and cancer antigen 199 (CA199) in pleural fluid samples for lung cancer.

METHODSImmunoprotein quantity of CEA, CA125, CA153 and CA199 was analyzed in pleural fluid and serum from patients with lung cancer (52 cases) and in pleural fluid from non cancerous patients (50 cases) by chemiluminescence.

RESULTSThe levels of CEA, CA125, CA153 and CA199 in pleural fluid of patients with lung cancer were significantly higher than those of non cancerous patients ( P < 0.01 or P < 0.05). In lung cancer patients, the levels of CEA, CA125, CA153 and CA199 in pleural fluid were obviously higher than those in serum ( P < 0.01 or P < 0.05). The sensitivity and the specificity of CEA+CA199 were 96.2% and 96.0%, respectively.

CONCLUSIONSDetection of CEA, CA125, CA153 and CA199 in pleural fluid might be helpful for diagnosing lung cancer, and the optimal combination for assay is CEA+CA199.